NCT05300464

A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection

Recruiting now NA Last updated 6 January 2025

What this trial tests

NA trial testing Clinical investigation medical device class IIa marked CE in Breast Cancer in 600 participants. Currently enrolling.

Timeline

7 January 2023

Primary endpoint
30 September 2026

31 January 2027

Quick facts

Lead sponsor	Umbria Bioengineering Technologies
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	600
Start date	7 January 2023
Primary completion	30 September 2026
Estimated completion	31 January 2027
Sites	3 locations across Italy, Spain

Drugs / interventions tested

• Clinical investigation medical device class IIa marked CE

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Umbria Bioengineering Technologies

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicentric, single arm, prospective, stratified by breast density clinical investigation to confirm the ability of the microwave mammogram 'MammoWave' to detect breast lesions.

MammoWave is a innovative medical device, class IIa marked CE, which uses microwaves instead of ionazing radiation (x-ray) for breast lesions. Specifically MammoWave employs a novel technique wich generates images by processing very low power (\<1mW) microwave.

The MammoWave exam takes few minutes for breast and is performed with the patient lying in a confortable facing down position.

MammoWave is safe to be used at any age, in any condition (pregnancy, specific illness and for unlimited number of times.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Multicentric, Single Arm, Prospective, Stratified Clinical Investigation to Confirm MammoWave's Ability in Breast Lesions Detection.
   Álvarez Sánchez-Bayuela D, Ghavami N, Romero Castellano C, Bigotti A, et al · · 2023 · cited 5× · PMID 37370995 · DOI 10.3390/diagnostics13122100
2. Breast density classification using frequency-based features in microwave imaging.
   Taghipour-Gorjikolaie M, Khalesi B, Khalid B, Ghavami N, et al · · 2025 · PMID 41310083 · DOI 10.1038/s41598-025-28629-8
3. A Line-Source Approach for Simulating MammoWave Microwave Imaging Apparatus for Breast Lesion Detection.
   Ghavami N, Dudley S, Ghavami M, Tiberi G. · · 2025 · PMID 40573527 · DOI 10.3390/s25123640